Beverage Choice and Lifestyle Modification in Overweight Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Body Mass Index Percentile (BMI%)
研究概览
简要总结
The rise in childhood overweightness and concomitant increase in chronic disease risk warrants exploration into the effectiveness of interventions targeting the eating and activity habits of overweight youth. This research study developed and tested a "Beverage Choice and Lifestyle Modification" (BCLM) intervention for 4 to 8 year old children who are at-risk for being overweight or are overweight and who consume large amounts of sugar sweetened beverages and juice. The overall study objectives were to test the acceptability and effectiveness of the BCLM intervention for improving the weight status, energy (kcal) intake, beverage selections and beverage preferences of children in targeted age and BMI group. The investigators hypothesized that those children randomized to the BCLM group will show greater improvements in weight and Body Mass Index (BMI) status, beverage choices,and energy intake than those assigned to our Nutrition Education (NE) group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 4-8 years old
- •BMI≥85th percentile (based on age and sex)
- •consumes large (≥16 oz.day) sugar sweetened beverages
排除标准
- •Child has a serious medical condition
- •Signs of elevated psychopathology are present, as assessed by the Child Behavior Checklist (CBCL)
- •Parent demonstrates elevated psychiatric problems or eating disorders
- •Failure of parent or child to meet BMI criteria
结局指标
主要结局
Body Mass Index Percentile (BMI%)
时间窗: Baseline and Month 6
Change in BMI% will be measured from baseline to end of treatment (month 6).
Body Mass Index (BMI)
时间窗: Baseline and Month 6
Change in BMI will be measured from baseline to end of treatment (month 6).
Body Mass Index z-score (BMI-z)
时间窗: Baseline and month 6
Change in BMI-z will be measured from baseline to end of treatment (month 6).
Child percent overweight
时间窗: Baseline and Month 6
Change in child percent overweight will be measured from baseline to end of treatment (month 6).
Waist Circumference
时间窗: Baseline to Month 6
Change in waist circumference will be measured from baseline to end of treatment (month 6).
Energy (kcal) intake
时间窗: Baseline to Month 6
Change in energy intake (kcals/day) will be measured from baseline to end of treatment (month 6) using 3-day food diaries.
Sugar-sweetened beverage intake
时间窗: Baseline to Month 6
Change in sugar-sweetened beverage intake will be measured from baseline to end of treatment (month 6).
Treatment acceptance and satisfaction
时间窗: Month 6
Overall treatment acceptance and satisfaction will be measured at end of treatment.
次要结局
- Child preferences and motivation for sugar-sweetened beverages(Baseline and Month 6)